Purpose: This program provides support for short-term research training for medical students in aging research.

Mechanism of Support: This Funding Opportunity Announcement (FOA)
will utilize the Ruth L. Kirschstein National Research Service Award (NRSA)
Short-Term Institutional Research Training Grant (T35).

Funds Available and Anticipated Number of Awards: NIA intends to commit approximately $750,000 in FY 2010 to fund 4 to 6 new and renewal awards in response to this FOA.

Budget and Project Period: Awards for T35 Short-Term institutional NRSA research
training grants may be for project periods up to five years in duration
and are renewable. An applicant may
request direct costs of up to $130,000 per year. Because the nature and
scope of the proposed research training will vary from application to application,
it is anticipated that the size and duration of each award will also vary.
Although the financial plans of NIA provide support for this program,
awards pursuant to this FOA are contingent upon the availability of funds
and the receipt of a sufficient number of meritorious applications. Trainees selected for short-term training are
required to pursue research training for 2-3 months on a full-time basis. More
information may be found in Section III, 3.

Eligible Program Director(s)/Principal
Investigator(s) (PD/PI): An eligible Training PD/PI is any individual with the skills, knowledge,
successful past training record, and available resources necessary to
carry out the proposed research training program. The PD/PI should
be an established basic, behavioral, and/or clinical researcher at the
sponsoring institution. The PD/PI will be responsible for the selection
and appointment of eligible trainees to the NRSA training grant, for the
overall direction, management and administration of the research training
program, program evaluation, and the submission of all required forms in a
timely manner. Individuals from underrepresented racial and ethnic groups
as well as individuals with disabilities are always encouraged to apply
for NIH support.

Number
of PDs/PIs. More than one PD/PI (i.e., multiple PDs/PIs), may be designated on the
application.

Number of Applications: Applicants may submit more than one
application, provided the research training programs are scientifically
distinct. Application forms (PHS 398) and NRSA instructions are
available at: http://grants.nih.gov/grants/funding/phs398/phs398.html in an interactive format. For further assistance
contact Grants Info, Telephone (301) 435-0714, Email: GrantsInfo@nih.gov

Resubmissions: Resubmission applications are not permitted in response to this
FOA.

The National Institute on Aging is pursuing
this initiative to develop and/or enhance research training opportunities for
individuals interested in careers in biomedical, behavioral and clinical
research.

This short-term research training program is intended to:

expose medical students, early in their training, to the
excitement of ongoing research;

encourage medical students to consider pursuing, and to plan for
over time, either a basic science, health services, or clinical research career
in the areas of research that are important to the NIA;

increase the pool of physician scientists engaged in biomedical, clinical
or health services research in those areas necessary to continue the mission of
the NIA.

The key building blocks of the program will be a series of related
Institutional National Research Service Award (NRSA) grants (T35) that will
each provide support for training experiences of eight to twelve consecutive
weeks duration under the supervision of experienced researchers. The program
should contain a mix of didactic activities and research experiences
appropriate to the level and interests of the participating student class. NIA has
strong interests in continuing to diversify the research workforce committed to
advancing the fields of aging and geriatric research. Therefore, applicants are
strongly encouraged to make efforts to recruit medical students from diverse
backgrounds for these short-term training experiences. Students who are members
of ethnic or racial groups underrepresented in these fields and students with
disabilities are important targets for these extra recruitment efforts. Others
whose background and experience is likely to diversify the research questions
being addressed or medical conditions explored are also appropriate targets for
these efforts. Such students may include, for example, those from economically
disadvantaged backgrounds or those with extensive experience in different
cultures.

In carrying out their stewardship of human resource related
programs, NIA may request information essential to assess the effectiveness of
this program. Accordingly, you are hereby notified that you may be contacted
for periodic updates on various aspects of the students’ follow-up activities
and career choices and other information helpful in evaluating the impact of
the program.

The
American Federation for Aging Research (AFAR) is a nonprofit organization whose mission is to support
biomedical research and training on aging. AFAR has agreed to provide separate
and non-overlapping support for this program in concert with its mission.

AFAR seeks
to address the needs of an aging society including developing an
expanded research workforce to address the problems and challenges introduced
by this changing society. AFAR, with other partners, founded the
Medical Student Geriatric Scholars Program in 1994, to provide short-term
research, clinical and didactic support for medical students in allopathic or
osteopathic schools, to expose them to career opportunities in aging-related
research and academic geriatrics. Most recently, working with The National Institute on Aging and the John
A. Hartford Foundation, AFAR coordinated a national program to
provide short-term research training for medical students.

AFAR, wholly separate and distinct from the NIA
will facilitate the recruitment of medical students to the current NIA short
term training opportunity by organizing a web-site to be used to recruit
students for the training awards.

Students will be able to apply to a central
site and indicate their preferences for different schools participating in the
NIA short term training program. AFAR will make applications available on an
internal web-site accessible only by institutions awarded the short term training
award.

Awardees of the Ruth L. Kirschstein Research training
grant will be offered use of this site to indicate selection of candidates for
the program. Students may use the site to accept or reject an offer from a
particular program. AFAR will alert awardees to students who remain available
for selection by the participating programs.

AFAR will also work with
other organizations who share the goal of furthering the physician-scientist
workforce in aging and in geriatric research to enrich the training experiences
for the medical students. Such organizations may include the American
Geriatrics Society (supporting travel to its annual meeting) and the Hartford
Foundation (providing additional resources or additional slots for medical
students). AFAR also intends to contribute to this initiative by
providing funds to allow students’ travel to the American
Geriatrics Society (AGS) annual scientific meeting or similar meeting, to
participate in an AGS/AFAR student poster session and roundtable luncheon,
where students meet with peers and mentors in aging-related research and
academic geriatrics. They have also agreed to provide resources to
allow a national collaboration among the awardees in recruiting and selecting
trainees. See Section IV.6 “Other Submission Requirements and Information” for
further information.

This funding opportunity will use the Ruth L. Kirschstein National
Research Service T35 award mechanism. Awards may be made for periods up to 5
years and are renewable.

The Training Program Director/Principal Investigator (PD/PI) will be
solely responsible for planning, directing, and executing the proposed research
training program.

This funding opportunity announcement (FOA) uses the non-modular budget
format described in the PHS 398 application instructions (see http://grants.nih.gov/grants/funding/phs398/phs398.html). A detailed categorical budget for the
"Initial Budget Period" and the "Entire Proposed Period of Support"
is to be submitted with the application, following the instructions for
preparing an NRSA institutional research training application.

2. Funds
Available

NIA intends to commit approximately $750,000 in FY 2010 to fund 4
to 6 new and competing renewal grants in response to this FOA. An applicant may
request a project period of up to 5 years and a budget for direct costs of up
to $130,000 per year. Because the nature and scope of the proposed research
training will vary from application to application, it is anticipated that the
size and duration of each award will also vary. Although the financial plans of
NIA provide support for this program, awards pursuant to this FOA are
contingent upon the availability of funds and the receipt of a sufficient number
of meritorious applications.

Stipends may be supplemented from non-Federal funds, however,
under no circumstances may the conditions of the supplementation interfere
with, detract from or prolong the participant’s NRSA supported training
program. One use of supplemental funding could be to provide housing expenses,
as needed, for student participants from another medical school.

A Statement of Appointment form (PHS 2271, rev. 4/98) must be
submitted at the start of each trainee appointment and reappointment. This form
is available at the following URL address: http://grants.nih.gov/training/phs2271.pdf. Trainees supported under this program are not required to sign
an NRSA Payback Agreement;

however, they must submit an NRSA Termination Notice.

Training
Related Expenses (TRE): The applicant
institution may request the appropriate proportion of the NIH standard annual
NRSA Training Related Expenses to help defray other costs of the short-term
training experience, such as research supplies, tuition, fees, certain types of
travel, and other expenses. The FY 2009 amounts for TRE are $4,200 annually ($350
/month) for each predoctoral trainee. Health insurance is an allowable expense
that may be charged to the Trainee Related Expenses budget category but only to
the extent that the same health insurance fees are charged to non-Federally funded
students and postdoctoral individuals.

Facilities
and Administrative (F&A) Allowance: Grantees,
other than State, local, or Indian tribal governments, will receive F&A
costs at 8 percent of modified total direct costs (exclusive of tuition and
fees, health insurance (when still awarded in the tuition and fees category),
consortiums in excess of $25,000, and expenditures for equipment) rather than
on the basis of a negotiated rate agreement. State, local, and Indian tribal
government agencies are eligible for full F&A cost reimbursement. For this
policy, State universities or hospitals are not considered governmental
agencies.

Stipend
Supplementation, Compensation, and Other Income: The grantee institution is allowed to provide funds to an individual in
addition to the stipends paid by the NIH. Such additional amounts either may be
in the form of augmented stipends (supplementation) or in the form of
compensation, such as salary or tuition remission for services such as teaching
or serving as a laboratory assistant, provided the conditions described below
are met. Under no circumstances may the conditions of stipend supplementation or
the services provided for compensation interfere with, detract from, or prolong
the trainee's approved NRSA training program.

Supplementation: Grantees may supplement stipends from non-Federal funds provided
the supplementation is without obligation to the trainee. An organization
can determine what amount of stipend supplementation, if any, will be provided
according to its own formally established policies governing stipend
support. These policies must be consistently applied to all individuals
in a similar training status regardless of the source of funds. Federal
funds may not be used for stipend supplementation unless specifically
authorized under the terms of the program from which funds are derived.
An individual may use Federal educational loan funds or VA benefits when
permitted by those programs. Under no circumstances may PHS funds be used
for supplementation.

Compensation: Funds characterized as compensation may be paid to trainees only
when there is an employer-employee relationship, the payments are for services
rendered, and the situation otherwise meets all of the conditions and policies
in the NIH Grants Policy Statement. Additionally, compensation must be in
accordance with organizational policies consistently applied to both federally
and non-federally supported activities and must be supported by acceptable
accounting records that reflect the employer-employee relationship. An
institution may provide additional funds to a trainee in the form of
compensation (as salary and/or tuition remission) for services performed
outside of the responsibilities of the full-time NRSA-supported training such
as teaching or serving as a research assistant. A trainee may receive
compensation for services as a research assistant or in some other position on
a Federal research grant, including a DHHS research grant. However,
compensated services should occur on a limited, part-time basis apart from the
normal full-time research training activities. In addition, compensation may
not be paid from a research grant that supports the same research that is part
of the trainee’s planned training experience as approved in the institutional
training grant application. The Training PD/PI must approve all
instances of employment on research grants to verify that the circumstances
will not detract from or prolong the approved training program.

Educational
Loans or G.I. Bill: An individual may make use of Federal educational loan funds and
assistance under the Veterans Readjustment Benefits Act (G.I. Bill). Such funds
are not considered supplementation or compensation.

Only
domestic, non-profit, private or public institutions may apply for grants to
support National Research Service Award (NRSA) short-term research training
programs. Foreign institutions are not eligible to apply. The applicant
institution must have a strong and high quality research program in the area(s)
proposed for the research training and must have the requisite staff and
facilities on site to conduct the proposed research training program.

1.B.
Eligible Individuals

Any
individual with the skills, knowledge, and resources necessary to organize and
implement a high-quality research training program is invited to work with
their institution to develop an application for support. Individuals from
underrepresented racial and ethnic groups, individuals with disabilities, and
individuals from disadvantaged backgrounds are always encouraged to apply for
NIH support.

The Training
PD/PI should be an established basic, behavioral, and/or clinical researcher
with skills, knowledge, a successful past training record, and available
resources to conduct the proposed short-term research training program at the
sponsoring institution. The PD/PI will be responsible for the selection and
appointment of eligible trainees to receive short-term NRSA support, for the
overall direction, management and administration of the program, program
evaluation, and the submission of all required forms in a timely manner.

More than
one Training PD/PI (or multiple PD/PIs), may be designated on the application
for training programs that require a team approach and therefore clearly do not
fit the single PD/PI model, e.g., interdisciplinary of multidisciplinary
training. The decision to apply with a single PD/PI or a multiple PD/PIs
is the responsibility of the investigators and applicant organizations, and should
be determined and justified by the goals of the training program.
Applications for grants with multiple PD/PIs require additional
information. When considering multiple PD/PIs, please be aware that the
structure and governance of the PD/PI leadership team as well as the knowledge,
skills and experience of the individual PD/PI will be factored into the
assessment of the overall scientific merit of the application. Multiple
PD/PIs on a program share the authority and responsibility for leading and directing
the training program, intellectually and logistically. Each PD/PI is
responsible and accountable to the grantee organization for the proper conduct
of the program, including the submission of required reports.

Applications
with multiple Training PD/PIs must provide a Leadership Plan that emphasizes
how leadership by multiple PD/PIs will benefit the research training program
and the trainees. A single Contact PD/PI must be designated for the purpose of
communicating with the NIH, although other individuals may contact the NIH on
behalf of the Contact PD/PI when necessary. Because training programs are
intended to be coherent a single award will be made. NIH will not
allocate the budget or training positions between multiple PD/PIs. Multiple
PD/PI applications should include reasonable numbers of PD/PIs and each should
be included for a specific purpose. Multiple PD/PI applications should not include all mentors of the training grant as PD/PIs, except in unusual cases.

Additional
instructional information associated with the multiple PD/PI option is located
in the PHS 398 application, Part I, Section 4.1 (Face Page) and 4.2.3
(Senior/key Personnel) and 8.9.11 (Multiple PD/PI Leadership Plan). For
background information on the Multiple PD/PI initiative, see http://grants.nih.gov/grants/multi_pi/index.htm.

Number of Applications.Applicants
may submit more than one application, provided they are scientifically
distinct.

Resubmissions. Resubmission
applications are not permitted in response to this FOA.

Renewals.Renewal applications
are permitted in response to this FOA.

Training
Program: Trainees appointed to the short-term research
training program must have the opportunity to carry out supervised biomedical,
behavioral, or clinical research with the primary objective of developing or
enhancing their research skills and knowledge in preparation for a
health-related research career. Trainees must be able to commit full-time
effort, normally defined as 40 hours per week or as specified by the sponsoring
institution in accordance with its own policies, to the program and its related
research activities, consonant with NRSA guidelines. Within the full-time
training period, research trainees who are also training as clinicians must
devote their time to the proposed research training and must confine clinical
duties to those that are an integral part of the research training experience.

A
Kirschstein-NRSA institutional research training grant must be used to support
a program of full-time research training. It may not be used to
support studies leading to the M.D., D.D.S., or other clinical,
health-professional training except when those studies are part of a formal combined
research degree program, such as the M.D./Ph.D.

Eligible Trainees: Trainee Eligibility Requirements: NRSA
institutional short-term training grants are intended to introduce trainees to
research that would not otherwise be available through their regular course of
graduate study. Short-term training is not intended, and may not be used, to
support activities that would ordinarily be part of a research degree program. Trainees must have successfully completed at least one year at a
school of medicine or osteopathy, prior to participating in the program.
Evidence of such likelihood must be provided at the time of application. These
grants are intended to introduce students to research experiences that they
would not otherwise normally complete while medical students. Positions on NRSA short-term institutional
training grants may not be used for courses and study leading to an M.D.,
D.D.S. D.O., D.V.M., or other clinical, health professional degree, nor do they
support residency training. Research elective credit may be granted for
students who complete a short-term research training experience supported by
the T35. The decision to award elective credit will be at the discretion
of the sponsoring institution and must be consistent with the policies of the
institution. Any additional costs associated with the decision to allow
research elective credit may not be charged to the T35.

The training grant positions should not be
used in lieu of regular graduate stipends. Trainees supported by NRSA funds are
not considered to be in an employer-employee relationship with NIH or the
institution at which they are pursuing research training.

Trainees are required to pursue research
training for 2-3 months on a full-time basis devoting at least 40 hours per
week or as specified by the sponsoring institution in accordance with its own
policies, to the program. Within the full time training period, research
trainees in clinical areas must devote their time to the proposed research
training and must confine clinical and other duties to those that are an
integral part of the research training experience. Successful trainees may be
appointed for additional periods of short-term training, or when appropriate,
they may be encouraged to enter an extended period of full-time training supported
by an NRSA training grant or fellowship or an NIH career development award.
Individuals currently supported by other Federal Funds are not eligible for
duplicative trainee support from this program at the same time.

Trainee Citizenship: The
individual to be trained must be a citizen or a noncitizen national of the United States or have been lawfully admitted for permanent residence at the time of
appointment. Noncitizen nationals are people, who, although not citizens of the
United States, owe permanent allegiance to the United States. They generally
are people born in outlying possessions of the United States (e.g., American Samoa and Swains Island). Individuals who have been lawfully admitted for
permanent residence must have a currently valid Permanent Resident Card (USCIS
Form I-551) or other legal verification of such status. For example, if an
individual has the proper validation on his/her passport, a notarized photocopy
of the passport could suffice. Because there is a 6-month limitation on this
validation, it is the grantee’s responsibility to follow up and ensure that the
individual received the I-551 prior to the 6-month expiration date.

A notarized statement verifying possession of permanent residency
documentation must be submitted with the Statement of Appointment (PHS Form
2271). Individuals with a Conditional Permanent Resident status must first meet
full (non-conditional) Permanent Residency requirements before receiving
Kirschstein-NRSA support. Individuals on temporary or student visas are
not eligible for Kirschstein-NRSA support.

Trainees: Trainees
must be enrolled and in good standing and must have successfully completed at
least one year at an accredited school of medicine or osteopathy before
participating in the program and must provide evidence of such likelihood at
the time of application. An institution may support students enrolled at other
institutions, provided that a feasible plan for evaluating and monitoring the
short and long-term outcome of the students' research experiences is provided.

Applications
must be prepared using the most current PHS 398 research grant application instructions and forms. Applicants must follow the additional specific instructions for
institutional NRSA applications, located in Section 8. Applications must
have a D&B Data Universal Numbering System (DUNS) number as the universal
identifier when applying for Federal grants or cooperative agreements. The
D&B number can be obtained by calling (866) 705-5711 or through the web
site at http://www.dnb.com/us/. The D&B number should be entered on line 11 of the face page of
the PHS 398 form.

The title
and number of this funding opportunity must be typed in item (box) 2 only of
the face page of the application form and the YES box must be checked.

Applications with
Multiple PDs/PIs

When multiple PD/PIs are proposed, use the Face
Page-Continued page to provide items 3a – 3h for all PD/PIs. NIH requires one
PD/PI be designated as the “contact PD/PI” for all communications between the
PD/PIs and the agency. The contact PD/PI must meet all eligibility requirements
for PD/PI status in the same way as other PD/PIs, but has no special roles or
responsibilities within the project team beyond those mentioned above. The
contact PD/PI may be changed during the project period. The contact PD/PI
should be listed in block 3 of Form Page 1 (the Face Page), with all additional
PD/PIs listed on Form Page 1-Continued. When inserting the name of the PD/PI in
the header of each application page, use the name of the “Contact PD/PI, et.
al.” The contact PD/PI must be from the applicant organization if PD/PIs are
from more than one institution.

All individuals designated as PD/PI must be registered in the
eRA Commons and must be assigned the PD/PI role in that system (other roles
such as SO or IAR will not give the PD/PI the appropriate access to the
application records). Each PD/PI must include their respective eRA Commons ID
in the eRA Commons User Name field.

All projects proposing Multiple PDs/PIs will be required to
include a new section describing the leadership plan approach for the proposed
project.

Multiple PD/PI Leadership Plan: For
applications designating multiple PDs/PIs, a new section of the research plan,
entitled “Multiple PD/PI Leadership Plan” must be included. A rationale for
choosing a multiple PD/PI approach should be described. The governance and
organizational structure of the leadership team and the research project should
be described, and should include communication plans, process for making decisions
on scientific direction, and procedures for resolving conflicts. The roles
and administrative, technical, and scientific responsibilities for the project
or program should be delineated for the PDs/PIs and other collaborators.

If budget allocation is planned, the
distribution of resources to specific components of the project or the
individual PDs/PIs should be delineated in the Leadership Plan. In the event of
an award, the requested allocations may be reflected in a footnote on the
Notice of Award.

Prospective applicants are asked to submit a letter of intent
that includes the following information:

Descriptive
title of proposed research

Name, address,
and telephone number of the Principal Investigator

Names of other
key personnel

Participating
institutions

Number and title
of this funding opportunity

Although a letter of intent is not required, is not binding, and does
not enter into the review of a subsequent application, the information that it
contains allows IC staff to estimate the potential review workload and plan the
review.

Applications must be
prepared using the forms found in the PHS 398 instructions for preparing a
research grant application. Submit a signed, typewritten original of the
application, including the checklist, and three signed photocopies in one package to:

Applications
must be submitted on or before the application receipt date) described
above (Section IV.3.A.).

If an application is
received after that date, the application may be delayed in the review process
or not reviewed. Upon receipt, applications will be evaluated for completeness
by the CSR and for responsiveness by the reviewing Institute Incomplete and/or
non-responsive applications will not be reviewed.

The NIH will not
accept any application in response to this funding opportunity that is
essentially the same as one currently pending initial review, unless the
applicant withdraws the pending application. However, when a previously
unfunded application, originally submitted as an investigator-initiated
application, is to be submitted in response to a funding opportunity, it is to
be prepared as a NEW application. That is, the application for the funding
opportunity must not include an Introduction describing the changes and
improvements made, and the text must not be marked to indicate the changes from
the previous unfunded version of the application.

All NIH
awards are subject to the terms and conditions, cost principles, and other
considerations described in the NIH Grants Policy Statement. The Grants Policy Statement can be found at http://grants.nih.gov/grants/policy/policy.htm.

The National Research Service Award (NRSA) policies apply
to this program. Awards are contingent upon the availability of funds.
Furthermore, the duration of the award and the number of funding training
positions may be less than the levels recommended by the peer review group,
based on programmatic and budgetary considerations.

Funds for
continuation of support beyond the initial year are determined by the success
as described in the annual progress report, the timely submission of required
forms, and the availability of funds for continuation programs.

Pre-Award
Costs: Pre-award costs are not allowable charges for
stipends, tuition, or trainee travel on institutional training grants since
these costs may not be charged to the grant before the trainee appointment is
actually made. However, the policies governing the pre-award cost authority for
the expenditure of the other funds provided as training-related expense in a
training grant are permitted as follows:

A grantee
may, at its own risk and without NIH prior approval, incur obligations and
expenditures to cover costs up to 90 days before the beginning date of the
initial budget period of a new or competing continuation award if such costs:
are necessary to conduct the project, and would be allowable under the grant,
if awarded, without NIH prior approval. If specific expenditures would
otherwise require prior approval, the grantee must obtain NIH approval before
incurring the cost. NIH prior approval is required for any costs to be incurred
more than 90 days before the beginning date of the initial budget period of a
new or competing continuation award.

The
incurrence of pre-award costs in anticipation of a competing or non-competing
award imposes no obligation on NIH either to make the award or to increase the
amount of the approved budget if an award is made for less than the amount
anticipated and is inadequate to cover the pre-award costs incurred. NIH
expects the grantee to be fully aware that pre-award costs result in borrowing
against future support and that such borrowing must not impair the grantee's
ability to accomplish the project objectives in the approved time frame or in
any way adversely affect the conduct of the project.

Concurrent
Awards: An NRSA may not be held concurrently with
another federally sponsored fellowship, traineeship, or similar Federal award
that provides a stipend or otherwise duplicates provision of the NRSA.

Taxability
of Stipends: Section 117 of the Internal Revenue Code
applies to the tax treatment of scholarships and fellowships. Degree candidates
may exclude from gross income (for tax purposes) any amount used for course
tuition and related expenses, such as fees, books, supplies, and equipment,
required for courses of instruction at a qualified educational organization. Nondegree
candidates are required to report as gross income any monies paid on their
behalf for stipends or any course tuition and fees required for attendance.

The
taxability of stipends in no way alters the relationship between
Kirschstein-NRSA trainees and grantee organizations. Kirschstein-NRSA stipends
are not considered salaries. In addition, trainees supported under
Kirschstein-NRSA institutional research training grants are not considered to
be in an employee-employer relationship with NIH or the grantee organization
solely as a result of the Kirschstein-NRSA support. Interpretation and
implementation of the tax laws are the domain of the IRS and the courts. NIH
takes no position on what the status may be for a particular taxpayer, and it
does not have the authority to dispense tax advice. Individuals should consult
their local IRS office about the applicability of the law to their situation
and for information on their tax obligations.

6. Other Submission Requirements

NIA strongly encourages
applicants to share their application with AFAR and to share the results of the
peer review with them. The application may be sent to the American Federation
for Aging Research at the address below.

Research Training Program: Institutions may
request support for up to 18 trainees per year, based

on a full-time, three month appointment. A trainee must be
appointed for a minimum of two months (8 weeks) and a maximum of three months (12
weeks) during a budget period. Students may apply to participate in

the program for more than one year, i.e., during two or more
consecutive summers. All research training must be full-time during the
specified training period. It is expected that programs will provide a summer
research training program. The requested number of funded short-term training
slots must be justified in the application based on the magnitude and focus of
the research supported at the applicant and other co-applicant institutions,
with particular attention to the areas of research supported by the NIA, and to
the interest of qualified investigators who will serve as training faculty,
research mentors and role models. Students should be able to pursue basic,
clinical or health services research projects in the broad areas of geriatrics
and gerontology. Applications must describe a plan for didactic instruction of
the students as well as mentored research experiences. The research experiences
should be ones that are tailored to permit clear progress in the course of the
short-term training offered. Ideally the experiences should be planned to allow
the students a role in a presentation or abstract. The didactic instruction
should include training in the responsible conduct of research (see below).
Faculty who will be mentors for the students must be identified in the
application together with biographical information reflecting their prior
experience in similar programs.

Applications may request support to recruit students who choose to
stay at their current medical school and receive mentoring and instruction from
researchers at that school. Applicants should include the list of schools
considered eligible to participate in this outreach instruction and identify
faculty at these schools who have agreed to serve as mentors. Biographical
information that includes the mentoring history of participating faculty at
outreach schools should be submitted as part of the application. If such
outreach schools are part of the application then applicants may consider
including one or two weeks of didactic instruction at the host school
(including training in the responsible conduct of research) to provide a common
orientation. Additional funds may be requested to cover travel and accommodation
of outreach students during this training. Where an applicant anticipates that
some students will remain at the distal school throughout the training period
the application should describe the arrangements that

have been made to ensure a shared training experience and training
in the responsible conduct of research.

The program
may provide didactic training as well as laboratory experience. This should
include a plan for determining trainee experience and needs and monitoring
progress to accomplish desired goals. The program should develop trainee skills
in understanding research, applying their critical abilities to conduct
research, identify problems in the process of conducting research, raise
questions and propose solutions to resolving problems. Trainees should be
prepared to take the information gleaned from the project to pursue future
research. The program should provide information and career guidance (when
applicable) describing the process of applying for future support.

Travel Expenses – Through application to AFAR in the appropriate
award years, the institution may request up to $1,000 per year per trainee to
help defray the cost of travel to a relevant scientific meeting. The meeting
should normally be the annual meeting of the American Geriatrics Society where
events are planned particularly for trainees from this program. The
foundations will supply the funds that allow student travel. The meeting will
typically be held in the year following the budget period in which the student
participates in his/her research training, particularly for students attending
the AGS annual scientific meeting, which is held in May.

The institution may additionally seek up to $1,000 per year per
trainee to cover travel and accommodation for any students at distal sites to
travel to the central training institution for one or two-week courses.
Institutions should estimate these costs in the initial application based on
the anticipated number of students to be recruited from distant locations.

Training Program Director/Principal
Investigator (PD/PI): The
Training PD/PI must possess the scientific background and leadership and
administrative capabilities required to coordinate, supervise, and direct the
proposed research training program. The PD/PI will be responsible for the
selection and appointment of trainees to the approved research training
program, and for the overall direction, management, administration, and
evaluation of the program. The PD/PI must provide potential
trainees information associated with NRSA programs and submit all required
trainee forms in a timely manner. If multiple PDs/PIs are involved in the
research training program, applicants must describe how the research training
program and trainees will benefit from the arrangement. A Leadership Plan
is required. See http://grants.nih.gov/grants/multi_pi/sample_leadership_plans.pdf. and information in 8.9.11 of the PHS 398
instructions.

Institutional
Environment, Commitment, and Resource: The
administration of the applicant institution as well as all participating units
and departments should include information in the application that documents
institutional support and commitment to the goals of the short-term research
training program. The application should include a description of support
(financial and otherwise) to be provided to the proposed program. This could
include, for example, space, shared laboratory facilities and equipment, funds
for curriculum development, release time for the PD/PI and/or participating
faculty, support for additional trainees in the program, or any other creative
ways to improve the climate for the establishment and growth of the research
training program.

Training
Program Evaluation:The
application must describe an evaluation plan to review and determine the
quality and effectiveness of the training program. This should include
plans to obtain feedback from current and former trainees to help identify
weaknesses in the training program and to provide suggestions for program
improvements, as well as plans for assessing trainees’ career development and
progression, including publications, degree completion, and post-training
positions. Evaluation results should be included in future competing
continuation (renewal) applications and as part of the Final Progress Report.

Recruitment
Plan: Applicants must submit a recruitment
plan for recruiting trainees from both outside and inside their sponsoring
institutions. The application should describe any recruitment and
outreach plan to increase the depth and diversity of the applicant pool
including those underrepresented in the current scientific research workforce
in the area of the proposed research training.

Recruitment
and Retention Plan to Enhance Diversity: The
NIH recognizes a unique and compelling need to promote diversity in the
biomedical, behavioral, clinical and social sciences workforce. The NIH
expects efforts to diversify the workforce to lead to the recruitment of the
most talented researchers from all groups; to improve the quality of the
educational and training environment; to balance and broaden the perspective in
setting research priorities; to improve the ability to recruit subjects from
diverse backgrounds into clinical research protocols; and to improve the nation’s
capacity to address and eliminate health disparities.

Accordingly
the NIH continues to encourage institutions to diversify their student and
faculty populations and thus to increase the participation of individuals
currently underrepresented in the biomedical, clinical, behavioral, and social
sciences such as: individuals from underrepresented racial and ethnic
groups, individuals with disabilities, and individuals from socially, culturally,
economically, or educationally disadvantaged backgrounds that have inhibited
their ability to pursue a career in health-related research. Institutions
are encouraged to identify candidates who will increase diversity on a national
or institutional basis. The NIH is particularly interested in encouraging
the recruitment and retention of the following classes of candidates:

A.
Individuals from racial and ethnic groups that have been shown by the National
Science Foundation to be underrepresented in health-related sciences on a
national basis (see http://www.nsf.gov/statistics/showpub.cfm?TopID=2&SubID=27)
In addition, it is recognized that under-representation can vary from setting
to setting and individuals from racial or ethnic groups that can be
convincingly demonstrated to be underrepresented by the grantee institution
should be encouraged to participate in this program.

B. Individuals
with disabilities, who are defined as those with a physical or mental
impairment that substantially limits one or more major life activities.

C. Individuals
from disadvantaged backgrounds who are defined as:

1.
Individuals who come from a family with an annual income below established
low-income thresholds. These thresholds are based on family size,
published by the U.S. Bureau of the Census; adjusted annually for changes in
the Consumer Price Index; and adjusted by the Secretary for use in all health
professions programs. The Secretary periodically publishes these income
levels at http://aspe.hhs.gov/poverty/index.shtml. For individuals from low income backgrounds, the institution must be
able to demonstrate that such candidates have qualified for Federal
disadvantaged assistance or they have received any of the following student
loans: Health Professional Student Loans (HPSL), Loans for Disadvantaged
Student Program, or they have received scholarships from the U.S. Department of
Health and Human Services under the Scholarship for Individuals with
Exceptional Financial Need.

2.
Individuals who come from a social, cultural, or educational environment such
as that found in certain rural or inner-city environments that have
demonstrably and recently directly inhibited the individual from obtaining the
knowledge, skills, and abilities necessary to develop and participate in a
research career. Recruitment and retention plans related to a
disadvantaged background are most applicable to high school and perhaps
undergraduate candidates, but would be more difficult to justify for
individuals beyond that level of achievement.

Competing
continuation and non-competing applications must include a detailed account of
experiences in recruiting individuals from underrepresented groups during the
previous funding period. Information must be included on successful and
unsuccessful recruitment strategies, including aggregate information on the
distribution of:

Students who applied for admission or positions within the
department(s) relative to the training grant,

Students who were offered admission to or a position within the
department(s),

Students actually enrolled in the summer research training program,

Students who were appointed to the research training grant.

For those
trainees who were enrolled in the academic program, the report should include
information about the duration of research training and whether those trainees
finished their training in good standing.

Peer
reviewers will separately evaluate the recruitment and retention plan to
enhance diversity after the overall score has been determined. Reviewers will
examine the strategies to be used in the recruitment and retention of
individuals from underrepresented groups. For renewal applications,
peer reviewers will evaluate whether the experience in recruitment during the
previous award period has been incorporated into the formulation of the plan
for the next award period. The review panel's evaluation will be included in an
administrative note in the summary statement. If the recruitment and retention
plan to enhance diversity is judged to be unacceptable, funding will be
withheld until a revised plan (and report) that addresses the deficiencies is
received. Staff within the NIH awarding component, with guidance from the
appropriate national advisory committee or council, will determine whether
amended plans and reports submitted after the initial review are acceptable.

This Program
Announcement requires all applicants to submit a recruitment and retention plan
to enhance diversity. Applications without a description of diversity
recruitment and retention plan will be considered incomplete and may be delayed
in the peer review process. Additional information on the required
Recruitment and Retention Plan to Enhance Diversity is available atFrequently
Asked Questions Recruitment and Retention Plan to Enhance Diversity (http://grants1.nih.gov/training/faq_diversity.htm).

Training in
the Responsible Conduct of Research:

Every
trainee must receive instruction in the responsible conduct of research.
Describe a plan to provide trainees with formal and informal instruction on
scientific integrity and ethical principles in research. The plan must address
the rationale for the instruction, the format and subject matter, the degree of
faculty participation, trainee attendance, plans to assess the quality and the
frequency of instruction. For Renewal applications, describe the type of instruction
provided in the current project period, the degree of student participation,
the results of any assessments and other relevant information.

There are no
specific curriculum or format requirements for this instruction; however, it is
strongly suggested that the instruction include: conflict of interest,
responsible authorship and publication, peer review, policies for handling
misconduct, policies regarding human subjects and live vertebrate animal
subjects in research, data management, data-sharing, collaborative research and
mentor-mentee relationships. Applicants may wish to consult the NIH web site at http://grants.nih.gov/training/responsibleconduct.htm and http://bioethics.od.nih.gov/researchethics.html for additional guidance.

Applications
lacking a plan for instruction in the responsible conduct of research will be
considered incomplete and will be returned to the applicant without review.

Trainees who
will participate in research involving human subjects must meet the NIH policy
requirement for education in human subjects protections (http://grants.nih.gov/grants/guide/notice-files/NOT-OD-00-039.html). Trainees participating in research with live vertebrate animals must
also be enrolled in the institutional animal welfare training program for
personnel who have contact with animals. The requirements for specific human
subjects education and participation in the institutional animal welfare
training program may be included as elements of required training in the
Responsible Conduct of Research.

6.B.
Resource Sharing Plans

Not Applicable

Section V. Application Review Information

1.
Criteria

Only the
review criteria described below will be considered in the review process.

Will undergo a selection process in which only those applications
deemed to have the highest scientific merit, generally the top half of
applications under review, will be discussed and assigned an impact/priority
score

Will receive a written critique

Will receive a second level of review by the National Advisory
Council on Aging.

The
following will be considered in making funding decisions:

Scientific merit of the proposed project as determined by peer
review

Relevance to program priorities

Availability of funds

The goals of NIH-supported research training programs are to help ensure
that a diverse pool of highly trained scientists are available in adequate
numbers and in appropriate research areas to address the Nation's biomedical,
behavioral, and clinical research needs. The scientific review group will
determine the quality of the proposed research training program and consider
whether the requested number of trainee positions is appropriate for the
short-term program.

All short-term research training applications will be evaluated for
merit by NIA initial review groups as follows:

Overall Impact. Reviewers will
provide an overall impact/priority score to reflect their assessment of the
likelihood for the project to promote the training of pre- and postdoctoral
fellows in biomedical, behavioral and clinical research, in consideration of
the following five core review criteria, and the additional review criteria (as
applicable for the project proposed).

Core Review Criteria. Reviewers will consider each of the five review criteria below in the
determination of scientific and technical merit, and give a separate score for
each. An application does not need to be strong in all categories to be
judged likely to have major scientific impact.

NIA research
training applications are evaluated using the following criteria:

Training
Program and Environment:

Are the research facilities and research environment conducive to
preparing trainees for successful careers as biomedical
scientists?

Do the objectives, design and direction of the proposed research
program ensure effective training?

Is the proposed program of training likely to ensure that trainees
will be prepared for successful and productive scientific
careers?

Do the courses, where relevant, and research training experiences
address state- of-the-art science relevant to the aims of the program?

Does the program provide training in inter- or multi-disciplinary
research and/or provide training in state of the art or novel
methodologies and techniques?

Is a significant level of institutional commitment to the program
evident?

Are the facilities, environment, and resources for the proposed
research training adequate and appropriate?

Does the program include features to encourage short-term trainees
to consider careers in health-related research?

Training
Program Director/Principal Investigator (PD/PI):

Does the Training PD/PI have the scientific background, expertise,
and experience to provide strong leadership, direction, management, and
administration to the proposed research training program?

Does the PD/PI plan to commit sufficient time to the program to
ensure its success?

Is sufficient administrative and research training support provided
for the program?

For applications designating multiple PD/PIs, is a strong
justification provided that the multiple PD/PI leadership approach will
benefit the training program and the trainees? Is a strong and
compelling leadership approach evident, including the designated roles and
responsibilities, governance, and organizational structure consistent with
and justified by the aims of the training program and with the
complementary expertise of each of the PD/PIs?

Preceptors/Mentors:

Are sufficient numbers of experienced preceptors/mentors with
appropriate expertise and funding available to support the number and
level of trainees proposed in the application?

Do the preceptors/mentors have strong records as researchers,
including successful competition for research support in areas directly
related to the proposed research training program?

Do the preceptors/mentors have strong records of training pre-
and/or postdoctorates?

Trainees:

Is a recruitment plan proposed with strategies to attract
high-quality trainees?

Are there well-defined and justified selection criteria and
retention strategies?

Is a competitive applicant pool in sufficient numbers to warrant
the proposed size and levels (predoctoral, postdoctoral and/or short-term)
of the training program in evidence?

Does the program have the potential or evidence to recruit high
quality, short-term trainees?

For competing renewal applications, how successful has the program
been in attracting and retaining individuals from diverse populations,
including populations underrepresented in science?

Training
Record:

How successful are the trainees (or for new applications, other
past students/fellows in similar training) in completing the
program?

How productive are trainees (or for new applications other past
students/fellows) in terms of research accomplishments and publications?

How successful are trainees (or other past students/fellows) in
obtaining further training appointments, fellowships, and career
development awards?

How successful are the trainees in achieving productive scientific careers,
as evidenced by successful competition for research grants, receipt of
honors or awards, high-impact publications, receipt of patents, promotion
to scientific leadership positions, and/or other such measures of success?

Does the program have a rigorous evaluation plan to review the
quality and effectiveness of the training? Are effective mechanisms
in place for obtaining feedback from current and former trainees and
monitoring trainees’ subsequent career development?

For renewal applications, does the application describe the
program’s accomplishments over the past funding period(s); are changes
proposed that would improve/strengthen the training experience?

Are plans presented to follow the careers of short-term trainees
and to assess the effect of the training program on subsequent career
choices? What is the success in attracting students back for
multiple appointments?

2.A.
Additional Review Criteria

In addition
to the above criteria, where appropriate, the following items will continue to
be considered in the determination of the scientific merit and the
impact/priority score (considered in overall impact/priority score), but
will not give separate scores for these items.

Protections
for Human Subjects: The involvement of human subjects and
protections from research risk relating to their participation in the proposed
research will be assessed (see the PHS 398 research grant application
instructions, Research Plan, section 5.5, item 8 on Human
Subjects).

Inclusion of
Women and Minorities in Research: The adequacy
of plans to include subjects from both genders and all racial and ethnic groups
(and subgroups), as appropriate for the scientific goals of the research, will
be assessed. Plans for the recruitment and retention of subjects will also be
evaluated (see the PHS 398 research grant application instructions, Research
Plan, sections 9 and 11 on the Inclusion of Women and Minorities and the
Inclusion of Children).

Care and Use
of Vertebrate Animals in Research: If
vertebrate animals are to be used in the project, the five items described in
the PHS 398 research grant application instructions, Research Plan, section
5.5., item 12 will be assessed.

Biohazards: If materials or procedures are proposed that are potentially hazardous
to research personnel and/or the environment, determine if the proposed
protection is adequate.

2.B.
Additional Review Considerations

As
applicable for the project proposed, reviewers will address each of the
following items, but will not give scores for these items and should not
consider them in providing an overall impact/priority score.

Budget: Reviewers will consider whether the budget and the requested
period of support are fully justified and reasonable in relation to the
proposed research. The priority score should not be affected by the evaluation
of the budget.

Recruitment
and Retention Plan to Enhance Diversity: The
NIH recognizes a unique and compelling need to promote diversity in the
biomedical, behavioral, clinical and social sciences workforce. The NIH
expects efforts to diversify the work force to lead to the recruitment of the
most talented researchers from all groups, to improve the quality of the
educational and training environment, to balance and broaden the perspective in
setting research priorities, to improve the ability to recruit subjects from
diverse backgrounds into clinical research protocols, and to improve the
Nation’s capacity to address and eliminate health disparities.

Accordingly
the NIH continues to encourage institutions to diversify their student and
faculty populations and thus to increase the participation of individuals
currently underrepresented in the biomedical, clinical, behavioral, and social
sciences such as: individuals from underrepresented racial and ethnic groups,
individuals with disabilities, and individuals from socially, culturally,
economically, or educationally disadvantaged backgrounds that have inhibited
their ability to pursue a career in health-related research. Institutions
are encouraged to identify candidates who will increase diversity on a national
or institutional basis.

Peer
reviewers will separately evaluate the recruitment and retention plan to
enhance diversity after the overall score has been determined. Reviewers
will examine the strategies to be used in the recruitment and retention of
individuals from underrepresented groups. The review panel’s evaluation
will be included in an administrative note in the summary statement. If
the diversity recruitment and retention plan is judged to be unacceptable,
funding will be withheld until a revised plan (and report) that addresses the
deficiencies is received. Staff within the NIH, with guidance from the
appropriate national advisory committee or council, will determine whether
amended plans and reports submitted after the initial review are acceptable.

Training in
the Responsible Conduct of Research: Peer
reviewers will assess the applicant’s plan for training in the responsible
conduct of research on the basis of the appropriateness of topics, format,
amount and nature of faculty participation, and the frequency and duration of
instruction.

The plan
will be discussed after the overall determination of merit, and the review
panel’s evaluation of the plan will not be a factor in the determination of the
overall impact/priority score. Plans will be judged as acceptable or
unacceptable, and the result will be described in an administrative note on the
summary statement. Regardless of the overall impact/priority score,
applications with unacceptable plans will not be funded until the applicant
provides an acceptable, revised plan. The relevant NIH staff will judge
the acceptability of the revised plan.

2.C.
Resource Sharing Plans

The
following resource sharing policies do not apply to this FOA:

Data Sharing Plan. Not Applicable

Sharing Model Organisms. Not Applicable

Genome Wide Association Studies (GWAS).

3.
Anticipated Announcement and Award Dates

Not applicable.

Section VI. Award Administration Information

1. Award
Notices

After the
peer review of the application is completed, the Training PD/PI will be able to
access the written critique called a Summary Statement via the eRA
Commons.

If the
application is under consideration for funding, NIH will request
"just-in-time" information from the applicant. For details,
applicants may refer to the NIH Grants Policy Statement Part II: Terms and
Conditions of NIH Grant Awards, Subpart A: General (http://grants.nih.gov/archive/grants/policy/nihgps_2003/index.htm).

A formal
notification in the form of a Notice of Award (NoA) will be provided to the
applicant organization. The NoA signed by the grants management officer is the
authorizing document. Once all administrative and programmatic issues have been
resolved, the NoA will be generated via email notification from the awarding
component to the grantee business official.

Selection of
an application for award is not an authorization to begin performance. Any
costs incurred before receipt of the NoA are at the recipient's risk. These
costs may be reimbursed only to the extent considered allowable pre-award
costs. See Also Section IV.5. Funding Restrictions.

Carryover of
unobligated balances: NIA requires prior
written approval for carryover of funds from one budget period to the next. When
required, such requests must include compelling justification including the
status of trainee appointments to the program.

Termination
of award: NIH may terminate a Kirschstein-NRSA
institutional research training grant before its normal expiration date if it
determines that the grantee has materially failed to comply with the terms and
conditions of the award or to carry out the purpose for which the award was
made. If an award is terminated for cause, NIH will notify the grantee
organization in writing of this determination, the reasons for the
determination, the effective date, and the right to appeal the decision. NIH
also may terminate an award at the request of the grantee.

An
organization wanting to terminate a training grant before the scheduled
termination date must notify the NIH awarding office immediately. In such
cases, NIH will issue a revised NGA to specify the changed period of support
and to show prorated trainee stipends, depending on the amount of time spent in
training.

Change of
institution: Kirschstein-NRSA institutional research
training grants may not be transferred from one domestic organization to
another except under the most unusual circumstances. Such a change generally
will be approved by the NIH awarding office only if all of the major benefits
attributable to the original grant can be transferred and there is no negative
impact on trainees active in the program.

Change of
Training Program Director/Principal Investigator (PD/PI): If change of a Training PD/PI is necessary, support of the award is not
automatic but may be continued with prior written approval by the NIH funding
component, provided that the following conditions are met. The current PD/PI or
the grantee institution has submitted a written request for the change,
countersigned by the appropriate institutional business official, to program
staff at the NIH funding component describing the reasons for the change. The
Biographical Sketch of the proposed PD/PI, including a complete listing of
active research grant support, must be provided. The information in the request
must establish that the specific aims of the original peer-reviewed program
will remain unchanged under the direction of the new PD/PI and that the new
PD/PI has the appropriate research and administrative expertise to lead the
training program. This request must be submitted sufficiently in advance of the
requested effective date to allow the necessary time for review.

Change of
program: A rationale must be provided for any proposed
changes in the original, peer-reviewed research training program
objectives. Any change requires prior approval by program staff of the
NIH funding component. If the new program does not satisfy this requirement,
the award will be terminated.

The NRSA
instructions for the Non-Competing Grant Progress Report in, Form 2590) should
be followed. Note that a substitute budget page and a summary of trainee page
are to be included in the request for continuation support. The non-competing
budget page should list the names and levels of those trainees who are
continuing in the research training program. Information on each trainee
should also be included in the narrative portion of the Progress Report as
described in the PHS Form 2590 instructions. Additional information that
should be included in the annual progress report in concert with the PHS 2590
instructions:

A brief introductory description of the program objective.

Information describing which, if any, faculty and/or mentors
have left the program and which, if any, new individuals have been added;
for new faculty and/or mentors involved in the program, biographical
sketches should be included in the application.

A detailed account of experiences in recruiting individuals from
under-represented groups during the previous funding period must be
included. Information must be included on both successful and
unsuccessful recruitment strategies. The report should provide
aggregated information on the distribution of all applicants and those accepted
and appointed. The aggregated report also should include information on
individuals with disabilities and those from underrepresented groups and
disadvantaged backgrounds. For those who were enrolled in the
program, the report should include aggregated information about the
duration of research training and whether those trainees completed their
training in good standing.

Any recommended changes to improve the program, including those
resulting from feedback from current or former trainees (e.g. new mentors,
changes in courses, recruitment strategies, etc.)

3.A.
Additional Reporting Requirements

Financial
Status Report (FSR): An annual FSR is required and must be
submitted within 90 days of the end of each budget period. Continuation support
will not be provided until the required form is submitted and reviewed.

Trainee
Reporting Requirements: The institution must
submit a completed Statement of Appointment (PHS Form
2271) for each trainee appointed or reappointed
to the training grant. This Form must be submitted to NIA at or before the
start of each trainee’s appointment or reappointment. An appointment or
reappointment may begin any time during the budget period, but not before the
budget period start date of the grant year. No funds may be provided
until such documents are submitted. A notarized statement verifying
possession of permanent residency documentation must be submitted with the
Statement of Appointment (PHS Form 2271). Individuals with a Conditional
Permanent Resident status must first meet full (non-conditional) Permanent
Residency requirements before receiving Kirschstein-NRSA support.

Within 30
days of the end of the total support period for each trainee, the institution must
submit a Termination Notice (PHS 416-7) to the NIH. All trainees must submit a
termination notice as part of the closeout process. If the trainee has a
payback obligation, he or she must notify the NIH of any change in address and
submit Annual Payback Activities Certification Forms (PHS 6031-1) until the
payback service obligation is satisfied.

Failure by
the grantee to submit the required forms in a timely, complete, and accurate
manner may result in an expenditure disallowance or a delay in any continuation
funding for the award. Forms may be found on the NIH Web site at http://grants.nih.gov/grants/forms.htm.

Publication
and Sharing of Research Results: NIH
supports the practical application and sharing of outcomes of funded
research. Therefore, trainees should make the results and accomplishments
of their Kirschstein-NRSA research training activities available to the
research community and to the public at large. The grantee organization
should assist trainees in these activities, including the further development
of discoveries and inventions for furthering research and benefiting the
public. No restrictions should be placed on the publication of results in
a timely manner.

Trainees are
encouraged to submit reports of their findings for publication to the journals
of their choice. For each publication that results from a trainee’s
research, NIH support should be acknowledged by a footnote in language similar
to the following: “This investigation was supported by the National Institutes
of Health under Ruth L. Kirschstein National Research Service Award
(number). Its contents are solely the responsibility of the
authors and do not necessarily represent the official views of the NIH.”
In addition, federal funding must be acknowledged as provided in “Public Policy Requirements and Objectives-Availability of
Information-Acknowledgment of Federal Funding.”

Evaluation: In carrying out its stewardship of human
resource-related programs, the NIH may request information essential to an
assessment of the effectiveness of this Program. Accordingly, NRSA
participants should be notified that they may be contacted after the completion
of their appointment for periodic updates on various aspects of their
employment history, publications, support from research grants or contracts,
honors and awards, professional activities, and other information helpful in
evaluating the impact of the research training program.

Inventions: Traineeships made primarily for educational purposes are exempted from
the PHS invention requirements and thus invention reporting is not required for
institutional training grants.

Copyrights: Except as otherwise provided in the terms and conditions of the award,
the recipient is free to arrange for copyright without approval when
publications, data, or other copyrightable works are developed in the course of
work under a PHS grant-supported project or activity. Any such copyrighted or
copyrightable works shall be subject to a royalty-free, nonexclusive, and
irrevocable license to the Government to reproduce, publish, or otherwise use
them, and to authorize others to do so for Federal Government purposes.

Final
Reports: A Final Progress Report and Financial Status
Report are required at the end of the grant project period or upon
relinquishment of an award. Evaluation results should be included as part
of the Final Progress Report.

Human
Embryonic Stem Cells (hESC): Only
approved hESC lines listed on the NIH Human Embryonic Stem Cell Registry http://stemcells.nih.gov/registry/ may be used for research training activities. The abstract of the
application must provide the registry identifying numbers of the HESC lines to
be used.

Section VII. Agency Contacts

We encourage
your inquiries concerning this funding opportunity and welcome the opportunity
to answer questions from potential applicants. Inquiries may fall into three
areas: scientific/research, peer review, and financial or grants management
issues:

Human Subjects Protection: Federal regulations (45CFR46) require that
applications and proposals involving human subjects must be evaluated with
reference to the risks to the subjects, the adequacy of protection against
these risks, the potential benefits of the research to the subjects and others,
and the importance of the knowledge gained or to be gained (http://www.hhs.gov/ohrp/humansubjects/guidance/45cfr46.htm).

Data and Safety Monitoring Plan: Data and safety monitoring is required
for all types of clinical trials, including physiologic toxicity and
dose-finding studies (phase I); efficacy studies (Phase II); efficacy,
effectiveness and comparative trials (Phase III). Monitoring should be
commensurate with risk. The establishment of data and safety monitoring boards
(DSMBs) is required for multi-site clinical trials involving interventions that
entail potential risks to the participants (NIH Policy for Data and Safety
Monitoring, NIH Guide for Grants and Contracts, http://grants.nih.gov/grants/guide/notice-files/not98-084.html).

Sharing Research Data: Investigators submitting an NIH application
seeking $500,000 or more in direct costs in any single year are expected to
include a plan for data sharing or state why this is not possible (http://grants.nih.gov/grants/policy/data_sharing). Investigators
should seek guidance from their institutions, on issues related to
institutional policies and local institutional review board (IRB) rules, as
well as local, State and Federal laws and regulations, including the Privacy
Rule. Reviewers will consider the data sharing plan but will not factor the
plan into the determination of the scientific merit or the priority score.

Policy for
Genome-Wide Association Studies (GWAS): NIH is
interested in advancing genome-wide association studies (GWAS) to identify
common genetic factors that influence health and disease through a centralized
GWAS data repository. For the purposes of this policy, a genome-wide
association study is defined as any study of genetic variation across the
entire human genome that is designed to identify genetic associations with
observable traits (such as blood pressure or weight), or the presence or
absence of a disease or condition. All applications, regardless of the amount
requested, proposing a genome-wide association study are expected to provide a
plan for submission of GWAS data to the NIH-designated GWAS data repository, or
provide an appropriate explanation why submission to the repository is not
possible. Data repository management (submission and access) is governed by the
Policy for Sharing of Data Obtained in NIH Supported or Conducted Genome-Wide
Association Studies, NIH Guide NOT-OD-07-088. For
additional information, see http://grants.nih.gov/grants/gwas/

Sharing of
Model Organisms: NIH is
committed to support efforts that encourage sharing of important research
resources including the sharing of model organisms for biomedical research (see http://grants.nih.gov/grants/policy/model_organism/index.htm). At the same time the NIH recognizes the rights of grantees and
contractors to elect and retain title to subject inventions developed with
Federal funding pursuant to the Bayh-Dole Act (see the NIH Grants Policy Statement.
Beginning October 1, 2004, all investigators submitting an NIH application or
contract proposal are expected to include in the application/proposal a
description of a specific plan for sharing and distributing unique model
organism research resources generated using NIH funding or state why such sharing
is restricted or not possible. This will permit other researchers to benefit
from the resources developed with public funding. The inclusion of a model
organism sharing plan is not subject to a cost threshold in any year and is
expected to be included in all applications where the development of model
organisms is anticipated.

Access to
Research Data through the Freedom of Information Act: The Office of Management and Budget (OMB)
Circular A-110 has been revised to provide access to research data through the
Freedom of Information Act (FOIA) under some circumstances. Data that are: (1)
first produced in a project that is supported in whole or in part with Federal
funds; and (2) cited publicly and officially by a Federal agency in support of
an action that has the force and effect of law (i.e., a regulation) may be
accessed through FOIA. It is important for applicants to understand the basic
scope of this amendment. NIH has provided guidance at http://grants.nih.gov/grants/policy/a110/a110_guidance_dec1999.htm. Applicants may wish to place data collected under this funding
opportunity in a public archive, which can provide protections for the data and
manage the distribution for an indefinite period of time. If so, the
application should include a description of the archiving plan in the study
design and include information about this in the budget justification section
of the application. In addition, applicants should think about how to structure
informed consent statements and other human subjects procedures given the
potential for wider use of data collected under this award.

Inclusion of
Women And Minorities in Clinical Research: It is
the policy of the NIH that women and members of minority groups and their
sub-populations must be included in all NIH-supported clinical research
projects unless a clear and compelling justification is provided indicating
that inclusion is inappropriate with respect to the health of the subjects or
the purpose of the research. This policy results from the NIH Revitalization
Act of 1993 (Section 492B of Public Law 103-43). All investigators proposing
clinical research should read the "NIH Guidelines for Inclusion of Women
and Minorities as Subjects in Clinical Research (http://grants.nih.gov/grants/guide/notice-files/NOT-OD-02-001.html); a complete copy of the updated Guidelines is available at http://grants.nih.gov/grants/funding/women_min/guidelines_amended_10_2001.htm. The amended policy incorporates: the use of an NIH definition of
clinical research; updated racial and ethnic categories in compliance with the
new OMB standards; clarification of language governing NIH-defined Phase III
clinical trials consistent with the new PHS Form 398; and updated roles and
responsibilities of NIH staff and the extramural community. The policy
continues to require for all NIH-defined Phase III clinical trials that: a) all
applications or proposals and/or protocols must provide a description of plans
to conduct analyses, as appropriate, to address differences by sex/gender
and/or racial/ethnic groups, including subgroups if applicable; and b)
investigators must report annual accrual and progress in conducting analyses,
as appropriate, by sex/gender and/or racial/ethnic group differences.

Inclusion of Children as Participants in Clinical Research: The NIH
maintains a policy that children (i.e., individuals under the age of 21) must
be included in all clinical research, conducted or supported by the NIH, unless
there are scientific and ethical reasons not to include them.

Required Education on the Protection of Human Subject Participants: NIH
policy requires education on the protection of human subject participants for
all investigators submitting NIH applications for research involving human
subjects and individuals designated as key personnel. The policy is available
at http://grants.nih.gov/grants/guide/notice-files/NOT-OD-00-039.html.

NIH Public
Access Policy Requirement: In accordance with the
NIH Public Access Policy, investigators funded by the NIH
must submit or have submitted for them to the National Library of Medicine’s
PubMed Central (see http://www.pubmedcentral.nih.gov/), an electronic version of their final,
peer-reviewed manuscripts upon acceptance for publication, to be made publicly
available no later than 12 months after the official date of publication. The NIH Public Access Policy is available at (http://grants.nih.gov/grants/guide/notice-files/NOT-OD-08-033.html).For more information, see the Public Access
webpage at http://publicaccess.nih.gov/.

Standards
for Privacy of Individually Identifiable Health Information: The Department of Health and Human Services (DHHS) issued final
modification to the "Standards for Privacy of Individually Identifiable
Health Information", the "Privacy Rule", on August 14, 2002. The
Privacy Rule is a federal regulation under the Health Insurance Portability and
Accountability Act (HIPAA) of 1996 that governs the protection of individually
identifiable health information, and is administered and enforced by the DHHS
Office for Civil Rights (OCR).

Decisions about applicability and implementation of the Privacy Rule reside
with the researcher and his/her institution. The OCR website (http://www.hhs.gov/ocr/) provides information on the Privacy Rule, including a complete
Regulation Text and a set of decision tools on "Am I a covered
entity?" Information on the impact of the HIPAA Privacy Rule on NIH
processes involving the review, funding, and progress monitoring of grants,
cooperative agreements, and research contracts can be found at http://grants.nih.gov/grants/guide/notice-files/NOT-OD-03-025.html.

URLs in NIH Grant Applications or Appendices: All applications and
proposals for NIH funding must be self-contained within specified page
limitations. Unless otherwise specified in an NIH solicitation, Internet
addresses (URLs) should not be used to provide information necessary to the
review because reviewers are under no obligation to view the Internet sites.
Furthermore, we caution reviewers that their anonymity may be compromised when
they directly access an Internet site.

Healthy People 2010: The Public Health Service (PHS) is committed to
achieving the health promotion and disease prevention objectives of
"Healthy People 2010," a PHS-led national activity for setting
priority areas. This FOA is related to one or more of the priority areas.
Potential applicants may obtain a copy of "Healthy People 2010" at http://www.health.gov/healthypeople.

Authority and Regulations: This program is described in the Catalog of
Federal Domestic Assistance at http://www.cfda.gov/ and is not
subject to the intergovernmental review requirements of Executive Order 12372.
Awards are made under the authorization of Section 487 of the Public Health
Service Act as amended (42 USC 288) and under Federal Regulations 42 CFR
66. All awards are subject to the terms and conditions, cost principles,
and other considerations described in the NIH Grants Policy Statement. The NIH Grants Policy Statement can be found at http://grants.nih.gov/grants/policy/policy.htm.

The PHS strongly encourages all grant recipients to provide a smoke-free
workplace and discourage the use of all tobacco products. In addition, Public
Law 103-227, the Pro-Children Act of 1994, prohibits smoking in certain
facilities (or in some cases, any portion of a facility) in which regular or
routine education, library, day care, health care, or early childhood
development services are provided to children. This is consistent with the PHS
mission to protect and advance the physical and mental health of the American
people.

Loan Repayment Programs: NIH encourages applications for educational
loan repayment from qualified health professionals who have made a commitment
to pursue a research career involving clinical, pediatric, contraception,
infertility, and health disparities related areas. The LRP is an important
component of NIH's efforts to recruit and retain the next generation of
researchers by providing the means for developing a research career unfettered
by the burden of student loan debt. Note that an NIH grant is not required for
eligibility and concurrent career award and LRP applications are encouraged.
The periods of career award and LRP award may overlap providing the LRP
recipient with the required commitment of time and effort, as LRP awardees must
commit at least 50% of their time (at least 20 hours per week based on a 40
hour week) for two years to the research. For further information, please see: http://www.lrp.nih.gov.